Obstructive Sleep Apnea (OSA)
Conditions
Keywords
CPAP Obstructive Sleep Apnea Telemonitoring Digital Health Sleep Apnea Primary Health Care Adherence Remote Monitoring
Brief summary
Obstructive sleep apnea (OSA) is a prevalent sleep disorder associated with cardiovascular, metabolic, cognitive, and psychological complications. Continuous Positive Airway Pressure (CPAP) therapy is the gold standard treatment for moderate to severe OSA; however, long-term adherence remains a major challenge, particularly in real-world primary care settings. This study aims to evaluate the effectiveness of telemonitoring using CPAP devices in improving treatment adherence and clinical outcomes among patients with severe OSA receiving care within the Brazilian Primary Health Care system. This randomized controlled trial will include 200 adult participants with severe OSA who are new users of CPAP therapy and are followed by primary health care units in the Southeast Regional Health Coordination of São Paulo, Brazil. Participants will be randomly allocated into two groups: a telemonitoring intervention group, monitored remotely through the AirView® platform and the myAir® application, and a control group receiving standard care without telemonitoring. Primary outcomes include CPAP adherence and residual apnea-hypopnea index (AHI). Secondary outcomes include daytime sleepiness, sleep quality, mood, cognitive complaints, and patient perceptions of care. Quantitative clinical data will be collected through CPAP telemonitoring systems and standardized questionnaires, while qualitative data will be obtained through semi-structured interviews with patients and health professionals. The results of this study may provide evidence supporting the integration of digital health technologies into primary health care services to improve adherence to CPAP therapy and optimize the management of obstructive sleep apnea in public health systems.
Detailed description
Obstructive sleep apnea (OSA) is a chronic sleep-related breathing disorder characterized by recurrent episodes of upper airway obstruction during sleep, leading to intermittent hypoxia and sleep fragmentation. OSA is associated with increased risk of cardiovascular disease, metabolic disorders, neurocognitive impairment, mood disturbances, and reduced quality of life. Continuous Positive Airway Pressure (CPAP) therapy is the most effective treatment for moderate to severe OSA. Despite its proven clinical benefits, adherence to CPAP therapy remains suboptimal in many patients. Barriers to adherence include discomfort with the device, technical difficulties, lack of support, and limited follow-up after treatment initiation. Recent advances in digital health technologies have enabled remote monitoring of CPAP usage and performance. Telemonitoring systems allow healthcare professionals to track adherence, identify technical issues, and provide timely interventions to support patients during treatment. However, evidence regarding the effectiveness of telemonitoring in real-world primary care settings within public health systems remains limited. This study aims to evaluate the impact of CPAP telemonitoring integrated into primary health care on treatment adherence and clinical outcomes among patients with severe OSA. The study will be conducted within the Primary Health Care network of the Southeast Regional Health Coordination of São Paulo, Brazil. A total of 200 adult participants aged 18 to 75 years with a confirmed diagnosis of severe obstructive sleep apnea (apnea-hypopnea index ≥30 events per hour) and who have initiated CPAP therapy within the previous 30 days will be recruited from participating primary health care units. Participants will be randomly assigned in a 1:1 ratio to one of two groups: Intervention group (Telemonitoring): Participants will receive remote monitoring through the AirView® platform (ResMed) and the myAir® mobile application. Healthcare professionals will monitor CPAP usage data, including nightly usage time, residual AHI, leak levels, and therapy pressure. When adherence problems or technical issues are detected, the primary health care team will provide support through phone calls, educational reinforcement, or home visits. Control group (Standard care): Participants will receive routine follow-up provided by primary health care services without access to telemonitoring tools or mobile applications. Participants will be followed for 12 months, with data collection at baseline, 3 months, 6 months, and 12 months. Primary outcomes include: * CPAP adherence (average nightly use and percentage of nights with ≥4 hours of use) * Residual apnea-hypopnea index (AHI) Secondary outcomes include: * Daytime sleepiness assessed using the Epworth Sleepiness Scale * Sleep quality assessed using the Pittsburgh Sleep Quality Index * Anxiety and depressive symptoms assessed using the Hospital Anxiety and Depression Scale * Cognitive complaints assessed using the Cognitive Failures Questionnaire * Patient and health professional perceptions regarding telemonitoring and care processes Quantitative analyses will be conducted using mixed statistical models to evaluate longitudinal outcomes. Qualitative data obtained from semi-structured interviews will be analyzed using thematic content analysis. This study seeks to generate evidence regarding the feasibility and effectiveness of telemonitoring strategies for CPAP therapy within public primary health care systems. The findings may support the implementation of digital monitoring strategies to improve adherence, optimize resource utilization, and enhance the management of obstructive sleep apnea in large-scale health systems.
Interventions
DEVICECPAP Telemonitoring
Continuous Positive Airway Pressure (CPAP) therapy with remote monitoring using the AirView® platform and myAir® application. The system allows healthcare professionals to monitor adherence, residual events, mask leak, and therapy parameters and provide early support to improve treatment adherence.
DEVICECPAP Therapy
Standard Continuous Positive Airway Pressure (CPAP) therapy prescribed for the treatment of obstructive sleep apnea, with routine follow-up by primary health care services without remote monitoring.
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors responsible for applying psychometric instruments and questionnaires will remain blinded to participant group allocation.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: a telemonitoring group receiving remote monitoring of CPAP therapy through the AirView® platform and myAir® application, and a control group receiving standard care without telemonitoring. Participants will be followed for 12 months with periodic clinical and psychometric assessments.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 75 years. * Diagnosis of severe obstructive sleep apnea (OSA) confirmed by polysomnography with apnea-hypopnea index (AHI) ≥30 events/hour. * New CPAP users (≤30 days since initiation of CPAP therapy). * Resident within the coverage area of the Southeast Regional Health Coordination (CRS Sudeste), São Paulo, Brazil. * Ability to understand and sign the informed consent form.
Exclusion criteria
* Previous CPAP use for more than 30 days prior to enrollment. * Indication for bilevel ventilation (BiPAP) or non-invasive ventilation due to conditions such as hypoventilation syndromes, chronic hypercapnic COPD, or neuromuscular diseases. * Predominant central sleep apnea (≥50% central events) or Cheyne-Stokes respiration. * Recent unstable or severe comorbidity (e.g., decompensated heart failure, acute coronary syndrome within 30 days, stroke within 3 months). * Severe cognitive impairment or psychiatric disorder that prevents understanding of study procedures or adherence. * Conditions preventing safe use of CPAP mask (e.g., major craniofacial deformities, facial trauma, extensive facial skin lesions). * Inability to maintain follow-up in primary care services of CRS Sudeste. * Participation in another interventional clinical trial that may interfere with study outcomes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CPAP adherence | 90 days | Average nightly use of CPAP therapy measured in hours per night using device-generated data from the CPAP system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Residual Apnea-Hypopnea Index (AHI) | 90 days | Residual apnea-hypopnea index recorded by the CPAP device during therapy. |
| Mask leak | 90 days | Mean mask leak values recorded by the CPAP device during treatment. |
| Percentage of nights with CPAP use ≥4 hours | 90 days | Proportion of nights in which participants used CPAP therapy for at least 4 hours. |
| Treatment discontinuation rate | 90 days | Proportion of participants who discontinued CPAP therapy during the follow-up period. |
| Daytime sleepiness (Epworth Sleepiness Scale) | Baseline, 6 months and 12 months | Change in daytime sleepiness measured using the Epworth Sleepiness Scale (ESS). |
| Sleep quality (Pittsburgh Sleep Quality Index) | Baseline, 6 months and 12 months | Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). |
| Anxiety and depression symptoms (Hospital Anxiety and Depression Scale) | Baseline, 6 months and 12 months | Symptoms of anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS). |
| Self-reported cognitive failures | Baseline, 6 months and 12 months | Cognitive failures assessed using the Cognitive Failures Questionnaire (CFQ). |
Countries
Brazil
Contacts
CONTACTAndre Morente, PharmD
PRINCIPAL_INVESTIGATORGustavo Moreira, MD, PhD
Federal University of São Paulo UNIFESP
Outcome results
None listed